Tuesday, January 26, 2016

Crisis management for research scandals: the PR flacks speak

Bial is getting mixed reviews for its PR response to the clinical trial disaster in France. Here are three very different takes, from the Wall Street Journal Research and Compliance blog.

Halsey Knapp, partner at law firm Krevolin Horst: “With one volunteer dead and five others hospitalized, Bial, the Portuguese drug manufacturer which sponsored the experimental molecule used in this first-in-human clinical drug trial, owed a thorough explanation to the deceased’s family, the other participants, authorities and the public. Bial paid little heed to this prescription.“In its first news release, Bial said too little. The company gave insufficient information about the drug trial, the victims and how their injuries came about–even omitting details that would have cast it in a more favorable light. For example, Bial could have clarified how it halted the trials within hours of the first negative outcome. It could have explained that one of the stricken has left the hospital and the condition of the other four is serious but stable.“Instead, with impenetrable language more suitable for a medical journal, Bial noted the other victims’ condition ‘present a positive scenario.’ Bial forfeited the opportunity to become the single, authoritative source of information regarding this mishap–and thus invited others to define the narrative.”Richard Levick, chief executive, Levick: “Even before Bial first responded to the tragic death of a clinical trial participant, the company had several factors working in its favor. First, the very nature of clinical trials raises the possibility that adverse events can occur, albeit rarely. As such, a company that handles the situation effectively has a better probability of success than a company experiencing similar problems after a medication reaches the marketplace. Second, media and other interested parties turning to Google for information won’t find any past problems that could portend a disturbing trend, even if they dig five pages deep into the search results.“Bial used its peacetime wisely–building the trust and goodwill necessary to weather the storm. That’s apparent in media coverage that is, to date, not excessively critical. Bial’s initial statements are somewhat boilerplate–which is to be expected–but have done nothing to weaken its position. The company’s first statement on Jan. 15 articulated prompt action, shared the known facts and avoided speculation that could force backtracking later. It also demonstrated a commitment to transparency, regulatory compliance and cooperation with authorities. Subsequent statements on Jan. 17 and Jan. 19 were equally effective, demonstrating compassion for the patients and families and disclosing new details that had come to light.“All that said, there are developments that could complicate matters. With the cause still unknown, scientists and doctors are beginning to hypothesize, which could get the rumor mill churning and force Bial into a defensive position from which it has to fend off conjecture. Moving forward, Bial needs to identify the cause of the problems as soon as possible. Doing so will end potentially damaging speculation and enable the company to start taking the corrective actions that enable audiences to move on. The company earned itself the benefit of the doubt. The longer this drags out, the greater the chance it is squandered.”Judy Phair, APR, Fellow PRSA, president at Phair Advantage Communications: “In its public statements on a clinical drug trial resulting in the death of one volunteer and serious injury to five others, Bial has chosen to use cautious language coupled with an all-business, impersonal tone. This wary approach could have the effect of damaging Bial’s reputation with key stakeholders and inspiring greater safety concerns about clinical trials in general.“Bial positioned itself as an uninvolved bystander in its first statement on Jan. 15. Its use of the passive voice–‘We were informed that five participants showed severe symptoms’–distanced Bial from the developing tragedy. Following the death of one volunteer, Bial issued another statement offering ‘thoughts and solidarity’ to the family of the volunteer and saying it was working with health authorities ‘to understand the causes of this tragic and unfortunate situation.’ However, the statement did not mention sympathy for, or active involvement with, the other hospitalized volunteers and their families–or the 84 other volunteers who had been given the drug. In fact, a newspaper account indicates that the hospital–not Bial–contacted the 84 who had been exposed to the drug to come in for full check-ups.“Bial’s final statement–four days after its initial response–finally expresses ‘deep regret’ for the death of one volunteer and says it is ‘closely following’ the health of the other hospitalized volunteers. It gives more detail about their statuses and pledges to continue to follow their conditions. While the last statement finally shows some engagement and sensitivity, Bial will need to ensure future communications express concern and involvement with all of the volunteers. It should accept responsibility, as a drug maker, for monitoring and, if necessary, improving current trial standards and for the well-being of all the volunteers in this trial. It’s time for Bial to replace corporate-speak with clear, empathetic, and humane communication–and the active voice.”

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Fear and Loathing in Bioethics began life as blog for "Investigative Journalism and Bioethics," a class taught by Amy Snow Landa and Carl Elliott at the University of Minnesota. Although the class has ended, the blog has not. Most posts now are by Carl Elliott, a professor in the Center for Bioethics. However, they do not in any way represent the views or positions of the University of Minnesota.